FDAFDA · Food and drugs·Recall number Z-1944-2014
syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.
Published July 9, 2014 · Recall initiated: May 20, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the Laboratory Information System (LIS) that should have been held for manual review.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- Worldwide Distribution. US Nationwide, Canada, Australia, Belgium, Czech Republic, Germany, Denmark, Finland, France, United Kingdom, Italy, Netherlands, Portugal, Slovakia, Singapore, Japan, and Spain.
- Lot
- syngo Lab Data Manager Application Software versions VA11B, VA12A, and VA12B
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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